Kornimate/medical-research-clean huggingface dataset:
oral valganciclovir versus valacyclovir

Conditions: Chronic Lymphocytic Leukemia; Leukemia

Summary: to determine if the rate of cytomegalovirus reactivation during treatment with alemtuzumab (campath) is reduced by the use of valganciclovir prophylaxis.

researchers will study the effectiveness of valganciclovir to help prevent cytomegalovirus infections in patients receiving alemtuzumab. since alemtuzumab eliminates t-cells, which are the body's usual defense against viruses, patients taking alemtuzumab have an increased risk of developing cmv. before treatment, you will have a physical exam. you will also have around 3-4 tablespoons of blood drawn for routine tests and for tests to see if you have ever been exposed to cmv. you will be randomly assigned (as in the toss of a coin) to one of two treatment groups. participants in one group will be given treatment with valganciclovir. participants in the other group will be given treatment with valacyclovir. this drug protects against herpes infections but not cmv. if you are assigned to the group that will receive valganciclovir, you will take valganciclovir by mouth once a day starting of your first day of alemtuzumab therapy. you will continue to take valganciclovir for 2 months after the end of alemtuzumab therapy. if you are assigned to the group that will receive valacyclovir, you will take valacyclovir by mouth once a day starting of your first day of alemtuzumab therapy. you will continue to take valacyclovir for 2 months after the end of alemtuzumab therapy. every 2 weeks while you are receiving alemtuzumab (usually 4-12 weeks)you will have a repeat blood test to look for cmv. your participation in this study will last for a maximum of 5 months. this is an investigational study. both valganciclovir and valacyclovir are fda approved and commercially available. however, the use of valganciclovir for this study is experimental. valganciclovir will be provided free of charge during the study.

Eligibility criteria:
inclusion criteria: * patients receiving alemtuzumab * age \> 15 * signed informed consent form exclusion criteria: * active cytomegalovirus disease or infection. asymptomatic patients with positive cmv pp65 antigenemia will not be excluded. * patients with a creatinine clearance of \< 10 ml/min as calculated via the cockcroft-gault equation.

Keywords: chronic lymphocytic leukemia cll leukemia
real-world study of serplulimab in 2l and above treatment of cervical cancer

Conditions: Cervical Cancer

Summary: this study is a prospective, multicenter, non-interventive real-world study to evaluate the efficacy and safety of the treatment of serplulimab in patients with advanced,recurrent and metastatic cervical cancer. approximately 118 eligible subjects are planned to be enrolled across all sites.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at time of study entry. * histologically or cytologically confirmed advanced, recurrent or metastatic cervical cancer. * received at least 1 prior systemic therapies in the recurrent or metastatic setting. tumor progression or recurrence after treatment with therapy. * ecog performance status of 0 or 1. * patient must have at least one measurable disease as defined by recist 1.1. * ability to provide written and signed informed consent. exclusion criteria: * pregnant or lactating women. * life expectancy \< 3 months * ongoing participation in another clinical study, or planned initiation of treatment in this study less than 14 days from the end of treatment in the previous clinical study. * known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody. * the patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
omni 3.0 surgical system in subjects with primary open-angle glaucoma

Conditions: Primary Open Angle Glaucoma

Summary: to gain early evidence of safety and assess the effectiveness of the intraocular pressure (iop)-lowering effectiveness of the omni 3.0 surgical system in primary open-angel glaucoma (poag).

to assess the safety of the omni 3.0 surgical system and gain early evidence on intraocular pressure (iop) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (poag).

Eligibility criteria:
inclusion criteria: * male or female subjects, 45 years or older * visually significant age-related cataract and requiring phacoemulsification cataract surgery, or, pseudophakic and a minimum of six months since cataract surgery. * intraocular pressure (iop) at the screening visit not exceeding 33 mmhg and at least 21 mmhg for unmedicated eyes or 16 mmhg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months. * diagnosed with mild to moderate primary open angle glaucoma (poag). diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage exclusion criteria: * any of the following prior ocular procedures: * laser trabeculoplasty ≤180 days prior to baseline * durysta ≤12 months prior to baseline * any implanted glaucoma device * prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy * ciliary ablation including endoscopic cyclophotocoagulation (ecp), cyclophotocoagulation or cpc (g probe), high intensity focused ultrasound (hifu), ≤180 days prior to baseline * retinal laser procedure ≤3 months prior to baseline * any form of glaucoma other than poag. * use of topical ocular steroids. * clinically significant concurrent ocular pathology or systemic medical condition which, in the investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet age-related macular degeneration (amd), corneal edema, fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to screening visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits). dry amd and non- proliferative diabetic retinopathy are not excluded. * history of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable iop measurement, e.g. keratoconus or abnormally thick (≥ 620 µm) or thin (≤ 480 µm) cornea. * retrobulbar tumor, thyroid eye disease, sturge-weber syndrome or any other type of condition that may cause elevated episcleral venous pressure. * bcva of logmar 0.4 (20/50) or worse in the study eye not due to cataract. * bcva of logmar 0.6 (20/80) or worse in the non-study eye not due to cataract.
effect of vitamin c supplementation in corneal endothelial damage in phacoemulsification of patients with hard cataracts

Conditions: Endothelial Cell Loss, Corneal; Cataract and Intraocular Lens (IOL) Surgery

Summary: the goal of this clinical trial is to analyze the protective effects of oral ascorbic acid on the corneal endothelial layer undergoing oxidative stress due to phacoemulsification in patients with hard cataracts. the main questions it aims to answer are: 1. will oral vitamin c administration provide better protection to the corneal endothelium in hard cataract phacoemulsification by comparing preoperative and postoperative administration, preoperative only, and no administration? 2. how does oxidative stress (mda levels) in the aqueous humour increase after oral vitamin c administration compared to no administration? 3. will there any changes in mda levels in the aqueous humour and blood after oral vitamin c administration compared to no administration? 4. does mda levels in the aqueous humour correlate with mda levels in the blood? researchers will compare vitamin c to a placebo to see if vitamin c as an antioxidant works in preventing corneal endothelial damage due to phacoemulsification. participants will: * take 500 mg of oral vitamin c or placebo three times a day for seven days prior to phacoemulsification * undergo phacoemulsification * take vitamin c or placebo three times a day for 28 days after phacoemulsification * visit the ophthalmology clinic 1, 7, 28, and 42 days post-operative for checkups * keep a logbook to record the drug they take and to write symptoms of possible side effect of the drug


Eligibility criteria:
inclusion criteria: * males and females aged 60 years or older * patients with immature senile cataracts in one or both eyes, with loc (lens opacities classification) iii nuclear opacity grade 4-6 and nuclear color grade 4-6 criteria * patients willing to undergo phacoemulsification cataract surgery and consume the study medication as allocated, as well as participate in follow-up assessments for 7 weeks * patients with no history of previous intraocular surgery * patients with no history of allergy to vitamin c * patients not routinely consuming other vitamins * patients who agree to and sign the informed consent for the study exclusion criteria: -

Keywords: cataract corneal endothelial damage phacoemulsification total antioxidant capacity ascorbic acid vitamin c supplementation malondialdehyde
xtract™ aspiration catheter registry study

Conditions: Fresh Soft Emboli or Thrombi in the Arteries.

Summary: intra-coronary thrombosis and thromboembolism continues to be a challenge for percutaneous coronary and other vascular interventional techniques. the xtract™ aspiration catheter is a single use device designed to remove fresh, soft emboli and thrombi from the arterial system using standard catheter techniques, compatible with 6 fr guide catheters and 0.014 guidewires. the purpose of this registry study is to validate the design and demonstrate the performance of the xtract aspiration catheter as a thrombectomy catheter during percutaneous intervention of vessels in the arterial system. subjects will be enrolled during percutaneous intervention when the interventional physician decides a thrombectomy catheter is needed to remove thrombus during the procedure.


Eligibility criteria:
inclusion criteria: * planned percutaneous intervention to a native coronary, coronary vein graft, renal artery or carotid artery lesion * angiographic evidence of thrombus.

Keywords: thrombus aspiration catheter
multiparametric pet-mri integration for a new approach to tumor heterogeneity in non-small cell lung cancer (nsclc): pilot study

Conditions: NSCLC

Summary: to estimate the intra and inter-operator reproducibility of multiparametric regional pet-mri mapping in locally advanced and trace mestastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: 1. locally advanced nsclc (stages iib, iiia or iiib of the tnm classification 7th edition) or trace metastatic stage iv (\</=5 mestastasis, \</= 3 organ reached) 2. exclusive therapeutic management by concomitant radio-chemotherapy administered in accordance with international recommendations (dual therapy with platinum salts) 3. signed consent 4. patients affiliated with the social security scheme or beneficiary of a similar scheme. exclusion criteria: 1. minor 2. pregnant / lactating woman 3. person deprived of liberty by judicial or administrative decision, adults who are the subject of a legal protection measure or unable to express their consent 4. previous cancer in the 2 years prior to registration 5. previousradiotherapy / thoracic surgery 6. patients under experimental treatment or for whom the administration of an experimental treatment is planned 7. claustrophobic patients 8. severe renal insufficiency (clearance mdrd cockroft \<30ml / min) 9. uncontrolled diabetes, hyperglycemia\> 1.8g / l 10. patient with metallic implants not compatible with mri or any immovable implanted electronic medical device (eg pacemaker, neurostimulator, cochlear implants, etc.)
a research study of a new medicine nnc0519-0130 in japanese and non-japanese men

Conditions: Diabetes Mellitus, Type 2

Summary: nnc0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. this study, will look into how safe the new medicine nnc0519-0130 is, and we will measure its concentrations in the blood and look at its effects. this study will last for a maximum of 22 weeks and japanese and non-japanese male participants will be included.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 23.0 kilogram per meter square (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). overweight should be due to excess adipose tissue, as judged by the investigator. * considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ecg) and clinical laboratory tests performed during the screening visit, as judged by the investigator. * for japanese participants: both parents of japanese descent. * for non-japanese participants: both parents of caucasian descent. exclusion criteria: * any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * glycosylated haemglobin (hba1c) greater than or equal to 6.5 percent (48 millimoles per mole \[mmol/mol\]) at screening. * use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (asa), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.
virtual observed therapy for patients with tuberculosis

Conditions: Tuberculosis

Summary: using modern technology, investigators will observe participants taking their tb tablets three times per week using a mobile phone, ipod or computer with camera facilities in the participants home environment.

using modern technology, the investigators will observe participants taking their tb tablets three times per week using a mobile phone, ipod or computer with camera facilities in the participants home environment. investigators will connect to the participants mobile phone, ipod or computer at a mutually convenient time three times per week who will observe participants taking their tb medication. the virtual observed therapy will be carried out using nhs lothian approved software (mobile app called polycom) three times per week. this is software similar to skype but polycom is the approved software we use in nhs lothian.

Eligibility criteria:
inclusion criteria: any patient requiring tuberculosis treatment exclusion criteria: those refusing consent; the healthcare professional deems the patient that will not be able to comply with vot

Keywords: tuberculosis management observed therapy
an investigation into the efficacy of a botanical supplement to provide period relief

Conditions: Menstrual Pain; Premenstrual Syndrome

Summary: women often experience significant pain during their periods which can significantly impact on quality of life. in this study, two products that are used to alleviate period pain will be examined. one test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. the trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. participants will use the botanical product alongside a traditional over-the-counter period product during their second period. participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.


Eligibility criteria:
inclusion criteria: * female between 18-40 years of age. * must be in good health with no significant chronic conditions and a bmi under 35. * must experience period pain and other pms symptoms. * must have a regular menstrual cycle with a bleed week. * if using hormonal contraception, must do so for at least three months * if using oral contraception, must allow for bleed week. * must be able to predict their bleed week. * willing to abstain from strenuous exercise 24 hours before each of the three blood draws in this trial. exclusion criteria: * suffers from pre-existing conditions that would prevent them from adhering to the protocol. * anyone with known severe allergic reactions. * anyone with a previous negative experience with acetaminophen. * unwilling to follow the study protocol. * currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study. * anyone who uses other supplements for period pain and pms symptoms. * current use of an extended activity hormonal contraception (examples include depo-provera or nexplanon.
the rate of c-reactive protein (crp) increase as a marker for bacterial infections in children

Conditions: Bacterial Infections; Viral Infection

Summary: fever is one of the most common problems in pediatrics. differentiating between bacterial infections, that require antibiotic therapy, and viral infections that resolve on their own is an important challenge for physicians. c-reactive protein (crp) is a protein that increases in response to inflammation and its level is generally higher in bacterial infections compared to viral infections. it can be measured by a simple blood test, however its utility as a sole marker for bacterial infection is limited. the hypothesis of the study is that measuring crp velocity, e.g the value of crp divided by the hours since the fever started will improve the utility of crp for the diagnosis of bacterial infections in children.


Eligibility criteria:
inclusion criteria: * children less than 5 years of age, * children with no comorbidities and fever \> 38 for at least 24 hours, and * children with no previous antibiotic therapy. exclusion criteria: * hiv, * immunosuppressive conditions, * antibiotic therapy.

Keywords: crp velocity
physical fitness, exercise self-efficacy, physical activity level in people with spinal cord injury (sci)

Conditions: Spinal Cord Injuries; Physical Disability

Summary: this is a single blind randomized controlled trial study which will conducted on people with paraplegia wheelchair users. the objectives of this study is to investigates the effects of 16 weeks of 'graded exercise integrated education' over conventional physical therapy on physical fitness, exercise self-efficacy and the level of physical activity. there will be a significant difference between the experimental and control group.

a study protocol will be a single blinded randomised controlled trial. 40 subjects with diagnosed of paraplegia (t1 and below) and dependent with wheelchair will be randomly assigned into 2 groups, graded exercise (n=20) or conventional physical therapy (n=20). in 8 weeks, the graded exercise group will receive strengthening and aerobic exercise for 2 times a week, and the controlled group will continue their normal routine. the strengthening exercise will consist of strength training for major upper limb muscles in the multigym station and free weights dumbbell whereas the aerobic exercise will perform by using arm ergometry, boxing and wheelchair wheeling. the exercise will be graded and progressed for each week in 8 weeks. the graded exercise group also will receive educational intervention to increase the exercise self-efficacy and physical activity level which will conduct in face to face for 2 times a week in 8 weeks during in-rehabilitation program and once on every 4 weeks in 8 weeks after discharge from in-rehabilitation program. the outcomes are the strength and endurance of upper limb which will be measure by using a biodex® isokinetic machine and hand grip strength by jamar® hand-held dynamometry. the cardiovascular endurance will be measure by using 6 minute wheelchair push test (6mwpt). the exercise self-efficacy and physical activity level will be measure by using 'exercise self-efficacy scale (eses)' and 'physical activity scale for individual with disability (pasipd)'. the outcome measure will be evaluated at the baseline level, week 4th, week 8th, week 12th, and 16th. statistical analysis will be carried out using the spss 21.0 program for windows and a significant level of p ≤ 0.05 will be used for all tests.

Eligibility criteria:
inclusion criteria: * traumatic and non-traumatic paraplegia * wheelchair dependent * age range between 18 and 65 years old exclusion criteria: * pregnancy * individual who suffered from progressive neurological diseases, depression and mental disorder * individual with frequent autonomic dysreflexia and hypotension * individual with comorbid recent fracture * individual with severe heart diseases and pain * individual who not understand malay and english * individual who not understand instructions and obey commands * individual who difficult to reach via telephone, email or social media

Keywords: spinal cord injuries physical fitness exercise self-efficacy physical activity
a study of evaluating the safety and efficacy of atg-010 combined with chemotherapy sequential with atg-010 monotherapy maintenance in peripheral t- and nk/t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma; NK/T-cell Lymphoma

Summary: this trial is proposed with treatment of atg-010 combined with chemotherapy regimens which will be chosen by investigators (ice \[ifosfamide+carboplatin+etoposide\] or gemox \[gemcitabine+oxaliplatin\] or tislelizumab), after treatments of 2 to 6 cycles transferring to atg-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of atg-010 in r/r ptcl and nk/t-cell lymphoma patients.

this trial is an open-label, multi-center phase ib clinical study that will evaluate atg-010 combined with chemotherapy regimen selected by investigators (ice regimen ifosfamide+carboplatin+etoposide; or gemox regimen: gemcitabine+oxaliplatin; tislelizumab) sequential atg 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in r/r ptcl and nk/t-cell lymphoma patients. 97 patients are planned to be enrolled.

Eligibility criteria:
inclusion criteria: 1. the patient is willing to provide written icf. 2. age≥ 18 years. 3. r/r ptcl and nk/t-cell lymphoma as confirmed by histological methods according to who classification of tumors of lymphoid tissues 2016. 4. previously received at least one or more standard regimens including anthracycline. 5. recurrence or the recurrence disease after the last treatment completed. 6. at least one measurable disease per modified efficacy assessment criteria (cheson 2014). 7. ecog ps 0 or 1. 8. any toxicity caused by previously anti-tumor therapy must recovered to ≤ grade 1 (nci-ctcae v5.0) with exception of hearing loss, alopecia, and pigmentation. 9. expected life time longer than 3 months. exclusion criteria: 1. current have disease or history of central nervous system lymphoma. 2. hbv-dna positive, or hcv-rna positive. 3. patients with a known history of human immunodeficiency virus (hiv) infection and/or acquired immunodeficiency syndrome. 4. received major surgery within 4 weeks of first dose of study drug 5. known received sine, including atg-010. 6. unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with atg-010 absorption. 7. known allergy to atg-010, or ice, or gemox. 8. a woman who is pregnant or nursing. 9. the investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.